Taiwan Cybersecurity Requirements Update

Taiwan Cybersecurity Requirements Update

On 21st November, the Taiwan Food and Drug Administration (TFDA) published the "Medical Device Cybersecurity Framework for Manufacturer". The TFDA issued the document to inform and encourage manufacturers to adopt a framework for the management of cybersecurity vulnerabilities throughout a product's lifecycle. The Framework is available in the annex. ARQon speculates that TFDA may require more documents for medical software submitted in the future.